BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR

    K Number: K103732 · Decision Feb 4, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    9
    Review Days
    44

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    Basic Information

    Device Name
    SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
    K Number
    K103732
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spacelabs Healthcare, Ltd.
    Date Received
    December 22, 2010
    Decision Date
    February 4, 2011
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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